EFFICACY AND SAFETY OF RECOMBINANT FOLLICLE-STIMULATING-HORMONE (PUREGON(R)) IN INFERTILE WOMEN PITUITARY-SUPPRESSED WITH TRIPTORELIN UNDERGOING IN-VITRO FERTILIZATION - A PROSPECTIVE, RANDOMIZED, ASSESSOR-BLIND, MULTICENTER TRIAL

The objective of this study was to compare the efficacy and safety of a recombinant follicle stimulating hormone (FSH) preparation (Org 3248 9, Puregon(R)) with a urinary FSH preparation (Metrodin(R)) in inferti le women undergoing in-vitro fertilization (IVF and embryo transfer an d who were pituitary-suppressed with triptorelin, In an assessor-blind , group-comparative, multicentre study, 60 women were randomized to Or g 32489 and 39 to urinary FSH. An evaluation of the main parameter, th e mean total number of oocytes recovered, indicated a similar efficacy for the two preparations: 9.7 with Org 32489 versus 8.9 with urinary FSH. In addition, there were no significant between-group differences with respect to other efficacy variables such as the total dose used, the duration of the treatment, the number of follicles greater than or equal to 17 mm In diameter and embryo quality, The ongoing pregnancy rates per attempt (30.2 versus 17.4%) and per transfer (34.0 versus 18 .8%) were higher with Org 32489, but this difference was not Statistic ally significant, No clinically relevant differences between Org 32489 and urinary FSH were seen with respect to safety variables, Serum ant ibodies were not detected in any of the subjects, It is concluded that Org 32489 compares favourably with urinary FSH in the treatment of in fertile pituitary-suppressed women undergoing IVF and embryo transfer.